Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
Healthy Volunteers
NCT05112588

Gestational Diabetes - PrEvention of PostPartum Diabetes Study

Led by Vastra Gotaland Region · Updated on 2024-06-13

600

Participants Needed

1

Research Sites

478 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gestational diabetes is the most common metabolic abnormality during pregnancy. In a Swedish population 2-10% of all pregnant women are diagnosed with gestational diabetes mellitus (GDM). The frequency differs dependent of methods for screening and diagnostic references, even within Sweden. Women with GDM have about 50% risk to develop manifest type 2 diabetes (T2DM) within 20 years. Most counties in Sweden have a recommendation to follow women with GDM yearly with an examination and an oral glucose tolerance test (OGTT). Unfortunately, this recommendation often fails, partly due to limited resources at the health care units but also due to lack of compliance from the women. Often after the baby is born focus is changed from the mother to the child and only 30.7% of the women with one or more risk factors performed an OGTT, despite stipulated OGTT in local guidelines. The diagnose GDM is under debate and Sweden has started to implement the recommendations from World Health Organisation (WHO) from 2013 with a lower cut-off for GDM, which will increase diagnostic sensitivity and consequently increase the number of women diagnosed with GDM. The plan was to conduct a randomized, clinical trial testing implementation the new recommendations in Sweden step-wise from 2018 and onwards. The recruitment is now complete and the results are expected to be published in 2021. The overarching aim of this study is to conduct a randomized, controlled clinical trial to test the effect of a model for a lifestyle intervention in clinical practice, using technical support as well as personal, individual support. The intervention is based on the existing organisation and structure in Primary Care and would thus be inexpensive and straight-forward to implement. An additive aim is to explore background mechanisms for the development of type 2 diabetes in women with gestational diabetes.

CONDITIONS

Official Title

Gestational Diabetes - PrEvention of PostPartum Diabetes Study

Who Can Participate

Age: 18Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with gestational diabetes
  • Provided signed informed consent
  • Expected to participate in regular child health care visits
  • Have internet access via computer, tablet, or phone
Not Eligible

You will not qualify if you...

  • Have diabetes mellitus diagnosed before pregnancy
  • Have other conditions or treatments affecting blood glucose control (e.g., endocrine disorders, cortisone medication)
  • Suspected type 1 diabetes based on antibodies or clinical history
  • Currently participating in another research study that may interfere
  • Have other diseases or conditions that prevent participation according to the Principal Investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Maternity Ward, Västra Götaland

Skövde, Sweden

Actively Recruiting

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Research Team

M

Margareta I Hellgren

CONTACT

B

Bledar P Daka

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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